Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: TANDEM™

• Registration Number: NCT01798134
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

This is a non-randomized, prospective, pilot, Multicenter Study of Drug-eluting bead transarterial chemoembolization (DEB-TACE) using Doxorubicin-Loaded Embozene® Tandem™ Microspheres to treat hepatocellular carcinoma (HCC).

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2013-02-22
• Study First Posted: 2013-02-25
• Primary Completion: 2014-11
• Study Completion: 2015-03
• Results First Submitted: 2016-05-18
• Results First Submitted QC: 2016-05-18
• Results First Posted: 2016-06-27
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-24
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Patients with a confirmed diagnosis of HCC according to the European Association for the Study of the Liver (EASL) criteria for diagnosis, and staged according to the Barcelona clinic liver cancer (BCLC) criteria
2. Subject is competent and willing to provide written informed consent in order to participate in the study
3. Adults (male or female) patients ≥ 18 years of age
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Child Pugh classification is 0-11
5. Multidonar or single nodular tumor ≥3-10cm, Patients with bilobar disease who can be treated superselectively in a single session or both lobes able to be treated within 3-5 weeks. Patient must have at least one tumor lesion that meets the following criteria: Lesion can be accurately measured in at least one dimension according to modified Response Evaluation Criteria In Solid Tumors (mRECIST) criteria
6. No invasion in the major blood vessel (hepatic portal, hepatic vein) or bile duct by the Magnetic resonance imaging (MRI) or Computed Tomography (CT)
7. Proper blood, liver, renal, heart function: testing result within 2 weeks from registry of this study
8. No current infections requiring antibiotic therapy
9. Not actively on cumarin based anticoagulation or suffering from a known bleeding disorder
10. Measurable disease per the Response Evaluation Criteria in Solid Tumors (mRECIST)
11. Expected survival more than 6 months

Read More

Exclusion Criteria

1. ECOG performance status >2; or Child-Pugh class C11 or more, or ASA class 5

2. Bilirubin levels >3 mg/dl

3. HCC with large vessel or biliary duct invasion, diffuse HCC or extrahepatic spread

4. Patients in which any of the following are contraindicated or present:

   • The use of doxorubicin
   • MRI
   • Hepatic embolization procedures
   • White blood cell (WBC) < 3000 cells/mm3
   • neutrophil < 1500 cells/mm3
   • Cardiac ejection fraction < 50 percent assessed by isotopic ventriculography, echocardiography or MR
   • Elevated creatinine greater than or equal to 2.5 mg/dl
   • Impaired clotting test (platelet count < 5 x 104/mm3, Prothrombin time-International normalized ratio (PT-INR > 2.0)
   • aspartate transaminase (AST) and/or alanine transaminase (ALT) >5x ULN or, when greater >250 U/L
   • Known hepatofugal blood flow
   • Arterio-venous shunt
   • Arterio-portal shunt
   • Main stem portal vein occlusion(point 6 in inclusion criteria)

5. Women who are pregnant or breast feeding

6. Allergy to iodinated contrast used for angiography

7. Tumour burden of more than 50% of liver

8. Patients with objective signs of active bacterial, viral (human immunodeficiency virus (HIV)), or fungal infection

9. Other primary malignancies or evidence of metastatic disease

10. Patients previously treated with anthracyclines (other than doxorubicin).

11. Any co-morbid disease or condition or event that, in the investigator's judgment, would place the patient at undue risk that would preclude the safe use of DEB-TACE.

12. Under no circumstances should patients be enrolled in this study who is already participating in another study for treatment of primary liver cancer.

13. Under no circumstances should patients be enrolled in this study who has received any other embolotherapy (including Selective Internal Radiation Therapy (SIRT)) for the treatment of primary liver cancer.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DEB-TACE	TANDEM™	Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE) Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin

Primary Outcome Measures

Name	Time	Method
Freedom From Study Related SAE at 6 Months	Up to 6 months
Freedom From Tumor Progression at 6 Months	6 months	Progression was assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST - Lencioni and Llovet 2010) as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
Freedom From Serious Adverse Event (SAE) at 30days	Up to 30 days

Secondary Outcome Measures

Name	Time	Method
12 Month Survival	12 months

Trial Locations

Locations (7)

Kilinikum Darmstadt; 🇩🇪 Darmstadt, Hessen, Germany

Universitatsklinikum Essen; 🇩🇪 Essen, Nordrhein-Westfalen, Germany

University Hospital Regensburg; 🇩🇪 Regensburg, Germany

Klinikum der Universitat Heidelberg; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany

SLK-Kliniken Heilbronn GmbH; 🇩🇪 Heilbronn, Baden-Wuerttemberg, Germany

Klinikum Stuttgart- Katharinenhospital; 🇩🇪 Stuttgart, Baden-Wuerttemberg, Germany

Klinikum Bogenhausen; 🇩🇪 Munchen, Bayern, Germany